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Fees and charges: summary from 1 July 2019

Version 1.1, July 2019

25 July 2019

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Prescription medicines

These fees apply to prescription medicines and other medicines that are evaluated as prescription medicines.

For clinical trials supplying unapproved medicines, go to Clinical trials.

Annual charges for prescription medicines

Table 1: Annual charges for prescription medicines
Type of prescription medicine Charge Regulation
Biological medicine $7,270

Item 7(1)(b)(i)(ii)(iii)

Item 7(2)(b)(i)(ii)(iii)

Non-biological medicine (chemical entity) - subsection 3-10 of regulation 8 $4,140 8(2)(a)
Non-biological medicine (chemical entity) - otherwise $3,360 8(2)(b)
Provisionally registered biological medicine $16,400 9(1)(a)
Provisionally registered non-biological medicine $13,400 9(1)(b)

These charges are in the Therapeutic Goods (Charges) Regulations 2018

More about chemical entities annual charges

Higher annual charges

Regulation 8 of the Therapeutic Goods (Charges) Regulations 2018 states when the higher annual charge applies for prescription medicine chemical entities.

Briefly, for prescription medicine chemical entities, a higher annual charge applies:

  • whatever the duration of registration, for medicines containing at least one specified active ingredient:
    • thalidomide
    • leflunomide
    • lenalidomide
    • mifepristone
    • clozapine
    • isotretinoin
  • until eight years have passed since registration, following an application for:
    • new chemical entity
    • extension of indications
    • change to intended patient group

Annual charges following applications for other major variations will incur higher or lower charges depending on the parent good, for example:

  • new formulation
  • change of strength
  • new dosage forms
Lower annual charges

The lower annual charge applies for:

  • most generic prescription medicines
  • most prescription medicines that are not biological medicines past the eighth anniversary of an application approval for a:
    • new chemical entity
    • extension of indications
    • or
    • change to intended patient group.

Application and evaluation fees for prescription medicines

Standard prescription medicine processes

These applications have both an application fee and an evaluation fee.

Table 2: Standard prescription medicine processes
Prescription medicine application type Application fee Evaluation fee Schedule 9, Part 2
New chemical entity* $48,800 $195,700 Item 2(ba) and Item 4(a)
Extension of indications* $29,100 $116,100 Item 2(bd) and Item 4(b)
Major variations*^ $19,000 $75,700 Item 2(bi) and Item 4(g)
Minor variation applications applied for under section 23 of the Act (Change in formulation, composition, design specifications, type of container or change of trade name)^ $1,120 $4,450 Item 2(bj) and Item 4(h)
Variations to an ARTG entry involving the evaluation of clinical, pre-clinical or bio-equivalence data, applied for under 9D(3) of the Act. Includes applications for changes to Product Information involving the evaluation of clinical, pre-clinical or bio-equivalence data*^ $1,120 $4,450 Item 2AC and Item 2C
Additional trade name^ $3,080 $12,300 Item 2(bh) and Item 4(d)
New generic product* $18,800 $74,700 Item 2(bg) and Item 4(c)
Extension of indications of a generic medicine to maintain currency with indications already registered to the corresponding innovator product and where clinical and/or bioequivalence data are not required $1,120 $4,450 Item 2(bk) and Item 4(bc)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990
'The Act' refers to the Therapeutic Goods Act 1989
n/a: not applicable;
* the fees are the same for the standard process and the comparable overseas regulator report-based process
^the fees are the same for registered and provisionally registered medicines

Priority review pathway for prescription medicines

These applications have both an application fee and an evaluation fee.

Table 3: Priority review pathway for prescription medicines
Prescription medicine application type Application fee Evaluation fee Schedule 9, Part 2
Priority determination of a prescription medicine $12,800 n/a Item 1B
New prescription medicine in the priority pathway $51,700 $207,000 Items 2(bca) and 4(ab)
New indications medicine in the priority pathway $30,800 $123,100 Items 2(bfa) and 4(bd)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990
n/a: not applicable

Provisional approval pathway for prescription medicines

These applications have both an application fee and an evaluation fee.

Table 4: Provisional approval pathway for prescription medicines
Prescription medicine application type Application fee Evaluation fee Schedule 9, Part 2
Provisional determination of a prescription medicine $12,800 n/a Item 1AA
Extension of provisional determination $ 4,610 n/a Item 1AB
Provisional registration of a new prescription medicine $48,900 $255,300 Items 1AC(a) and 1AD(a)
Provisional registration of a new indications medicine $29,200 $168,400 Items 1AC(b) and 1AD(b)
Extension of provisional registration $17,600 n/a Item 1AG
Transition from provisional registration to full registration* $29,100 $122,800 Items 1AE and 1AF

These fees are in Schedule 9, Therapeutic Goods Regulations 1990
n/a: not applicable;
*: Fees for an application under Section 23 for registration of a medicine that is included in the part of part of the ARTG for goods known as provisionally registered goods to be included in the part of the ARTG for goods known as registered goods

Requests with single fee

These requests have a single fee, instead of an application fee and an evaluation fee.

Table 5: Requests with single fee
Prescription medicine request Fee Schedule 9, Part 2
Variations to an ARTG entry, applied for under section 9D(3) of the Act, involving the evaluation of only chemistry, quality control or manufacturing data. Includes applications for changes to Product Information involving the evaluation of only chemistry, quality control or manufacturing information. $5,570 Item 2B
Minor editorial changes: variations to an ARTG entry (requiring changes to Product Information) with no evaluation of data $1,710 Item 2A(a)
Correction to an ARTG entry $1,710 Item 2A(a)
Notification request $810 Item 2CB
Self-assessable request with no evaluation of data $1,710 Item 2A(a)
Safety-related request with no evaluation of data $1,710 Item 2A(a)
Safety-related request with evaluation of data $5,570 Item 2CA
Request for advice in relation to a prescription medicine for the purpose of listing the medicine as a pharmaceutical benefit $2,260 Item 18
Application for consent by the Secretary under sections 14 and 14A of the Act to the import, export or supply of therapeutic goods that do not comply with an applicable standard. $480 Item 1A

These fees are in Schedule 9, Therapeutic Goods Regulations 1990.
"The Act" refers to the Therapeutic Goods Act 1989.

Medicines as components of devices

This table applies to prescription medicines used as an ancillary component of a medical device.

Table 6: Medicines as components of devices
Application type Application fee Evaluation fee Schedule 9, Part 2
New chemical entity of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing OR nonclinical studies $16,200 $65,300

Item 2(bb)

Item 4(aa)(i)

Item 4(aa)(ii)

New chemical entity of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing AND nonclinical studies $32,600 $130,200

Item 2(bc)

Item 4(aa)(iii)

Extension of indicators of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing OR nonclinical studies $9,680

$38,700

Item 2(be)(i)

Item 4(bb)(i)(a)

Item 4(bb)(ii)(a)

Extension of indications of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing AND nonclinical studies $19,500 $77,400

Item 2(bf)(i)

Item 4(bb)(iii)(a)

Major variation of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing OR nonclinical studies $6,320 $25,100

Item 2(be)(ii)

Item 4(bb)(i)(b),

Item 4(bb)(ii)(b)

Major variation of a medicine used as an ancillary medical component of a device - chemistry, quality control and manufacturing AND nonclinical studies $12,700 $50,600

Item 2(bf)(ii)

Item 4(bb)(iii)(b)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

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